A Phase 3 interventional study of Difluprednate Ophthalmic Emulsion in Uveitis and Panuveitis, sponsored by Sirion Therapeutics, Inc.. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2006-12-04.
Sponsored by Sirion Therapeutics, Inc. · Phase 3, Interventional, and Treatment
The purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.
The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.
39 studies on the registry are indexed under Panuveitis; 4 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 29 interventional studies indexed under Panuveitis.
Browse Panuveitis studies →Sirion Therapeutics, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Compared within Panuveitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Uveitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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A drug or device being studied in a clinical trial.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anterior chamber cell score was compared between baseline and Day 14.
The anterior chamber cell score was compared between baseline and Days 3 and 7.
The total symptom score (sum of eye pain, photophobia, blurred
vision, foreign body sensation and lacrimation scores) and total
sign score (sum of anterior chamber cell, anterior chamber flare,
ciliary hyperemia, keratic precipitate and synechia of iris and
posterior scores) were compared between baseline and Days 3, 7
and 14.
No study locations are listed for this record.
The record gives a start of Aug 2002 and a completion of Jun 2003. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Difluprednate
Sirion Therapeutics, Inc.